Biostatistics and Data Infrastructure core

生物统计和数据基础设施核心

• 批准号: 10507633
• 负责人: Marinella Temprosa
• 金额: $ 74.12万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2027-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10507633
• 关键词: Address; Adherence; Alzheimer' s Disease; Alzheimer' s disease related dementia; Ancillary Study; Biological Markers; Biological Specimen Banks; Biometry; Clinic; Clinical; Clinical Trials Data Monitoring Committees; Cognition; Cognitive; Collaborations; Custom; Data; Data Analyses; Data Collection; Data Reporting; Data Set; Development; Ensure; Goals; Infrastructure; Lead; Manuscripts; Mentors; Monitor; National Institute on Aging; Non-Insulin-Dependent Diabetes Mellitus; Online Systems; Outcome; Outcome Study; Persons; Plasma; Play; Prediabetes syndrome; Procedures; Process; Progress Reports; Protocols documentation; Publications; Quality Control; Reporting; Research Design; Research Personnel; Role; Sample Size; Standardization; Statistical Data Interpretation; System; Training; United States National Institutes of Health; Universities; Validation; Washington; adjudication; cognitive testing; data acquisition; data enclave; data infrastructure; data integrity; data management; data quality; data repository; data warehouse; design; diabetes prevention program; longitudinal analysis; multimodality; neuroimaging; novel strategies; operation; programs; repository; synergism; validation studies; web site

The Biostatistics and Data Infrastructure Core (Data Core) will provide statistical expertise and data infrastructure for the Diabetes Prevention Program (DPP) Outcomes Study (DPPOS) Alzheimer’s disease (AD) and AD related dementias (ADRD) Project. The Data Core statisticians will play a significant role from the design to the dissemination and close-out as we have done in DPP/DPPOS. The Data Core, led by Dr. Marinella Temprosa, will promote consistent analytical practices and definitions across the four projects, ancillary studies, and the manuscripts and presentations that emanate from the DPPOS AD/ADRD Project. In addition, the Data Core will support the Administrative Core, Clinical Operations and Procedures Core (Clinical Core), Cognitive Assessment and Adjudication Core (Cognition Core), and Neuroimaging and Plasma Biomarkers Core (Biomarkers Core) in activities that require data management and statistical analyses. The Data Core will ensure the continuity of DPP/DPPOS into the DPPOS AD/ADRD Project by overseeing all aspects of study design, power and sample sizes required to meet the proposed aims and determining analysis plans and performing data analyses. The Data Core will oversee the DPPOS AD/ADRD Project’s data collection and management, continue to ensure the same high-quality, accurate, reliable, and data integrity as has been done for the past 25 years in DPP/DPPOS. Finally, the Data Core will implement a program to allow investigators inside and outside the DPPOS AD/ADRD Project study group to analyze data to answer questions beyond those proposed in the DPPOS AD/ADRD Project as part of ancillary studies and manuscript proposals. The Data Core will achieve its goals through the following specific aims: (1) Provide statistical expertise for the four projects and activities of the other cores to promote scientific rigor in study design, study conduct, and the analyses and interpretation of data; (2) Provide data and reporting infrastructure for all the projects and other cores. The data core will leverage MIDAS (Multi- modal Integrated Data Acquisition System), a web-based custom-built system developed at George Washington University which has been used since 2009 for DPPOS for data capture and adjudication and the study website for reporting; (3) Maintain the central data warehouse and quality controls for all projects and other cores; (4) Disseminate data to facilitate ancillary studies, promote training in data analyses and for submission to the appropriate NIH repository, in collaboration with the Administrative Core. The Data Core will lead statistical and data management activities in the DPPOS AD/ADRD Project. The Data Core will collaborate and integrate all with other cores and projects and develop synergies to elucidate the course of AD/ADRD in persons living with pre-diabetes and type 2 diabetes.

生物统计和数据基础设施核心（数据核心）将提供统计专业知识和数据基础设施 糖尿病预防计划（DPP）结果研究（DPPOS）阿尔茨海默病（AD）和AD相关 痴呆症项目。数据核心统计人员将从设计到 传播和收尾，就像我们在DPP/DPPO中所做的那样。由Marinella Temprosa博士领导的数据核心， 将在四个项目、辅助研究和 来自DPPOS AD/ADRD项目的手稿和演示文稿。此外，数据核心将 支持行政核心、临床操作和程序核心（临床核心）、认知评估 和裁定核心（认知核心），以及神经影像学和血浆生物标志物核心（生物标志物核心）， 需要数据管理和统计分析的活动。数据核心将确保 通过监督研究设计、把握度和样本的所有方面，将DPP/DPPOS纳入DPPOS AD/ADRD项目 确定满足拟定目标所需的尺寸，并确定分析计划和进行数据分析。的 数据中心将监督DPPOS AD/ADRD项目的数据收集和管理，继续确保 与过去25年在DPP/DPPOS中所做的相同的高质量、准确、可靠和数据完整性。 最后，数据核心将实施一项计划，允许DPPOS AD/ADRD内外的调查人员 项目研究小组分析数据，以回答DPPOS AD/ADRD中提出的问题以外的问题 项目作为辅助研究和手稿建议的一部分。数据核心将通过以下方式实现其目标： 以下具体目标：（1）为其他核心的四个项目和活动提供统计专业知识， 促进研究设计、研究实施以及数据分析和解释的科学严谨性;（2）提供 所有项目和其他核心的数据和报告基础设施。数据核心将利用MIDAS（多 模态集成数据采集系统），这是一个基于Web的定制系统，由乔治华盛顿开发 自2009年以来一直用于DPPOS数据采集和裁定的大学和研究网站 （3）维护所有项目和其他核心项目的中央数据仓和质量控制;（4） 传播数据，以便利辅助研究，促进数据分析方面的培训， 适当的NIH存储库，与行政核心合作。数据核心将领导统计和 DPPOS AD/ADRD项目中的数据管理活动。数据核心将协作并整合所有 与其他核心和项目，并发展协同作用，以阐明AD/ADRD患者的病程， 糖尿病前期和2型糖尿病